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NCT Number: NCT07257809

Herombopag Treated T-DM1 Induced Platelet Reduction

This is a single-arm study planned to enroll 56 breast cancer patients who experienced grade 2 or higher thrombocytopenia following prior chemotherapy and achieved normalization (platelet count ≥100 × 109/L and ≥200 × 109/L) through intervention.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Tao Qin, MD

CONTACT

[email protected]

86-02034071337

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Age 18-75 years, any gender;
  • Pathologically diagnosed with breast cancer based on histological or cytological examination, and previously treated with neoadjuvant anti-HER-2 therapy followed by T-DM1 adjuvant therapy;
  • Experienced grade 2 or higher tumor treatment-related thrombocytopenia during the previous T-DM1 treatment cycle, with platelet count restored to ≥100 × 109/L and ≤200 × 109/L prior to the next treatment;
  • ECOG performance status score: 0-2;
  • Planned to undergo at least two additional treatment cycles including T-DM1 administration, with the dose of T-DM1 in the current cycle consistent with the previous cycle;
  • Expected survival of ≥12 weeks and able to tolerate the current treatment regimen for at least two cycles or more;
  • Expected to have good compliance, able to follow up on treatment efficacy and adverse reactions as required by the protocol.

Exclusion:

  • A history of other malignant tumors diagnosed within the past 3 years;
  • Patients with mental or neurological disorders who are unable to cooperate;
  • Patients who are scheduled to undergo or have previously undergone organ or bone marrow transplantation;
  • Patients with hematopoietic system disorders other than chemotherapy-induced thrombocytopenia (CTIT), including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndrome;
  • Patients with a history of any arterial or venous thrombotic events within the past 6 months prior to screening;
  • Severe bleeding manifestations within 2 weeks prior to screening, such as gastrointestinal or central nervous system bleeding;
  • Participation in a clinical trial of the same type of drug within 4 weeks prior to enrollment;
  • Pregnant or lactating women;
  • Patients with a history of hypersensitivity to the study drug;
  • Patients deemed ineligible by the investigator.

Treatment and study plan

herombopag olamine tablets

Drug

Herombopag 7.5 mg po qd,d1-14

Primary outcomes

  1. Proportion of grade I thrombocytopenia according to CTCAE4.0

    Time frame: From enrollment to the end of treatment at 6 weeks

    The proportion of patients with platelet counts <100 × 109/L according to CTCAE4.0

Secondary outcomes

  1. the proportion of salvage platelet transfusion therapy

    Time frame: From enrollment to the end of treatment at 6 weeks

    Proportion of patients requiring platelet transfusion therapy during treatment

  2. time to platelet counts ≥100 × 109/L

    Time frame: From enrollment to the end of treatment at 6 weeks

    Median time to achieve and maintain platelet counts ≥100 × 109/L from the start of Hetrombopag until the next treatment cycle;

  3. Proportion of T-DM1with unexpected administration

    Time frame: From enrollment to the end of treatment at 6 weeks

    Proportion of patients who experienced delay, dose reduction, or discontinuation of T-DM1 due to thrombocytopenia

  4. proportion of adverse events

    Time frame: From enrollment to the end of treatment at 6 weeks

    According to CTC AE 4.0 to evaluate profile of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Qin, MD

CONTACT

[email protected]

86-02034071337

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

A Multicenter, Single-arm Exploratory Clinical Study Evaluating the Efficacy and Safety of T-DM1 in Patients With Breast Cancer Who Developed Thrombocytopenia.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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